Simulation-Based Process Design for Asymmetric Single-Point Incremental Forming of Individual Titanium Alloy Hip Cup Prosthesis.

Advanced manufacturing techniques aimed at implants with high dependability, flexibility, and low manufacturing costs are crucial in meeting the growing demand for high-quality products such as biomedical implants. Incremental sheet forming is a promising flexible manufacturing approach for rapidly prototyping sheet metal components using low-cost tools. Titanium and its alloys are used to shape most biomedical implants because of their superior mechanical qualities, biocompatibility, low weight, and great structural strength. The poor formability of titanium sheets at room temperature, however, limits their widespread use. The goal of this research is to show that the gradual sheet formation of a titanium biomedical implant is possible. The possibility of creative and cost-effective concepts for the manufacture of such complicated shapes with significant wall angles is explored. A numerical simulation based on finite element modeling and a design process tailored for metal forming are used to complete the development. The mean of uniaxial tensile tests with a constant strain rate was used to study the flow behavior of the studied material. To forecast cracks, the obtained flow behavior was modeled using the behavior and failure models.

'Pre-launch' finite element analysis of a short-stem total hip arthroplasty system consisting of two implant types.

BACKGROUND: We applied a previously established and validated numerical model to a novel short-stemmed implant for a 'pre-launch' investigation. METHODS: The implant system consists of two different implant geometries for valgus/varus-positioned proximal femurs with differences in volume distribution, head/neck angle, and calcar alignment. The aim of the design was to achieve a better adaption to the anatomic conditions, resulting in a favourable load transfer. The implant type G showed the best fit to our model, but both stem geometries were implanted; the implant type B was used to compute an 'imperfection scenario'. FINDINGS: Apparent bone density decreased by 4.3% in the entire femur with the implant type G, and by 12.3% with the implant type B. Bone mass loss was pronounced in the proximal calcar region. Apparent bone density increased at the lateral cortical ring and in the minor trochanter. The apparent bone density in the imperfection scenario was very similar to that of a straight stem, indicating a distal load transfer. INTERPRETATION: No adverse effects of the A2 short-stemmed implant system on bone remodeling could be detected. The overall bone density reduction was acceptable, and wedge fixation was not observed, indicating that there was no distal load transfer. The simulation of an incongruous implant indicates the sensitivity of our model in response to modifications of implant positioning. Correct implant selection and positioning is crucial when using the A2 system.

Bone cyst formation after ankle arthroplasty may be caused by stress shielding. A numerical simulation of the strain adaptive bone remodelling.

BACKGROUND: The history of total ankle arthroplasty (TAA) has different evolution steps to improve the outcome. The third generation implants show an overall 8-year survival rate up to 93%. The main reported reason for early failure of TAA is aseptic loosening, cyst formation is also frequently reported. The aim of the present study is to use the finite element (FE) method to analyze the adaptive bone remodeling processes, including cyst formation after TAA. METHODS: Bone characteristics applied to the model corresponded to information obtained from computed tomography. Finite element models for the tibia and the talus were developed and implant components were virtually implanted. RESULTS: The calculated total bone loss is 2% in the tibia and 17% in the talus. Cysts and areas of increased bone density were detectable dependent on prosthesis design in the tibia and talus. CONCLUSION: Our FE simulation provides a theoretical explanation for cyst formation and increasing bone density depending on implant design. However, cysts are not mono-causal, histo-chemical reactions should also be considered. Further clinical studies are necessary to evaluate the relevance of cyst formation and therapeutic strategies.

Comparative investigation of bone mineral density using CT and DEXA in a canine femoral model.

Bone density measurements using computed tomography (CT) instead of dual-energy X-ray absorptiometry (DEXA) are currently of great interest in human and veterinary medical research as it would be beneficial to use CT scans obtained for other indications also for determining bone density. For Hounsfield units (HU) measured with CT in specific regions of interests (ROIs) in one or several slice/s a correlation with bone mineral density (BMD) measured by DEXA in humans and dogs of between 0.44 and 0.77 is reported in the literature. In the present study, instead certain volumes of interest (VOIs) obtained by CT scan and the corresponding HU to the respective VOIs were compared with the bone mineral density of the corresponding areas measured by DEXA. The aim of the study was to investigate whether this procedure gives more accurate information about bone density of the bones as three-dimensional objects of the respective patient. Correlation between measured HU in the respective VOI and BMD measured with DEXA in the corresponding ROI showed a very good correlation of 0.93. Linear regression with R2 = 0.85 (p = 0.0262) was calculated. Except for VOI5, similar distribution of values and significant differences (p < 0.0001-0.0087) between ROIs/VOIs were detected. Determining HU for assessing bone mineral density in a certain volume provides more accurate results than those previously reported from two-dimensional (2D) CT measurements. © 2017 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 35:2667-2672, 2017.

Finite element model of a novel short stemmed total hip arthroplasty implant developed from cross sectional CT scans.

BACKGROUND: Numerous short stemmed total hip arthroplasty (THA) implants have been introduced over the last decades. It is questionable if little differences between the implant designs affect stress shielding and bone remodeling. The finite element analysis allows an evaluation of the design rationale of the implant without negative side effects for the patient. OBJECTIVE: We investigated a relatively new short stemmed implant designed from clustered CT datasets of proximal femurs. How does the implant affect femoral bone remodeling? Can we see a positive effect on bone remodeling from the CT based design? METHODS: We used a Finite Element Model that was validated by a prospective dual-energy-x-ray-absorptiometry study to calculate apparent bone density. RESULTS: Apparent bone density (ABD) decreased by 2.3% in the entire femur. Bone mass loss was pronounced in the proximal calcar region. Little ABD increase was seen in the lateral aspect of the cortical ring, in the minor trochanter area and at the lateral aspect of the stem. CONCLUSIONS: ABD reduction occurs in the proximal regions of the femur. The overall bone mass loss was little after THA with the investigated implant. The specific design seems to have no major effect on stress shielding or load distribution.

Numeric simulation of bone remodelling patterns after implantation of a cementless straight stem.

PURPOSE: For further development of better bone-preserving implants in total hip arthroplasty (THA), we need to look back and analyse established and clinically approved implants to find out what made them successful. Finite element analysis can help do this by simulating periprosthetic bone remodelling under different conditions. Our aim was thus to establish a numerical model of the cementless straight stem for which good long-term results have been obtained. METHODS: We performed a numeric simulation of a cementless straight stem, which has been successfully used in its unaltered form since 1986/1987. We have 20 years of experience with this THA system and implanted it 555 times in 2012. We performed qualitative and quantitative validation using bone density data derived from a prospective dual-energy X-ray absorptiometry (DEXA) investigation. RESULTS: Bone mass loss converged to 9.25% for the entire femur. No change in bone density was calculated distal to the tip of the prosthesis. Bone mass decreased by 46.2% around the proximal half of the implant and by 7.6% in the diaphysis. The numeric model was in excellent agreement with DEXA data except for the calcar region, where deviation was 67.7%. CONCLUSIONS: The higher deviation in the calcar region is possibly a sign of the complex interactions between the titanium coating on the stem and the surrounding bone. We developed a validated numeric model to simulate bone remodelling for different stem-design modifications. We recommend that new THA implants undergo critical numeric simulation before clinical application.

Finite element model of a novel short stemmed total hip arthroplasty implant developed from cross sectional CT scans.

BACKGROUND: Numerous short stemmed total hip arthroplasty (THA) implants have been introduced over the last decades. It is questionable if little differences between the implant designs affect stress shielding and bone remodeling. The finite element analysis allows an evaluation of the design rationale of the implant without negative side effects for the patient.OBJECTIVE: We investigated a relatively new short stemmed implant designed from clustered CT datasets of proximal femurs. How does the implant affect femoral bone remodeling? Can we see a positive effect on bone remodeling from the CT based design? METHODS: We used a Finite Element Model that was validated by a prospective dual-energy-x-ray-absorptiometry study to calculate apparent bone density.RESULTS: Apparent bone density (ABD) decreased by 2.3% in the entire femur. Bone mass loss was pronounced in the proximal calcar region. Little ABD increase was seen in the lateral aspect of the cortical ring, in the minor trochanter area and at the lateral aspect of the stem. CONCLUSIONS: ABD reduction occurs in the proximal regions of the femur. The overall bone mass loss was little after THA with the investigated implant. The specific design seems to have no major effect on stress shielding or load distribution.

The cementless Bicontact stem in a prospective dual-energy X-ray absorptiometry study.

PURPOSE: The cementless Bicontact total hip arthroplasty (THA) system (AESCULAP AG, Tuttlingen, Germany) was introduced in 1986/1987 and has been in successful clinical use in an unaltered form up to today. Although good long-term results with the Bicontact stem have been published, it is questionable whether the implant provides the criteria for a state-of-the-art stem regarding proximal bone stock preservation. The purpose of the study was to monitor the periprosthetic bone mineral density (BMD) in a prospective two-year follow-up dual-energy X-ray absorptiometry (DEXA) study. METHODS: After power analysis, a consecutive series of 25 patients with unilateral Bicontact stem implantation was examined clinically and underwent DEXA examinations. Scans of seven regions of interest were taken preoperatively and at one week, six months, and one and two years. RESULTS: One patient required stem revision due to a deep infection. The Harris Hip Score increased significantly by 44 points. The most significant bone loss was observed in the calcar region (R7) in the first six months (-19.2 %). It recovered in the following 18 months to -8.5 %. The BMD in the greater trochanter dropped significantly after six months and remained stable at this level. BMD exceeded baseline values in distal regions and even more in the lesser trochanter region after two years. CONCLUSIONS: We conclude that the Bicontact stem provides adequate proximal bone stock preservation. We observed some signs of stress shielding at the tip of the stem, which is inevitable to some degree in THA with cementless straight stems. However, in this prospective DEXA investigation, we showed that proximal off-loading does not occur after THA with the Bicontact system. Thus, we believe that this stem is still a state-of-the-art implant.

Bone remodelling around a cementless straight THA stem: a prospective dual-energy X-ray absorptiometry study.

The design of the Bicontact® stem (BBraun, Aesculap, Tuttlingen, Germany) and the implantation technique have undergone no major alterations in the last 20 years leading, and good clinical results have been reported. The aim of our study was to investigate whether the implant encourages beneficial bone remodelling. Twenty-four patients were included in a prospective dual-energy X-ray absorptiometry (DEXA) study of this stem, after appropriate statistical power analysis. Preoperative and postoperative (1 week, 6 months, and 12 months) clinical and DEXA examinations were performed. The Harris Hip Score increased significantly by 39 points. The strongest decreases in BMD were observed in the greater trochanter region (-11%) and the calcar (-12%). In the second half of the study period the bone mineral density recovered slightly and even returned to baseline values in the lesser trochanter region. Therefore, proximal load transfer and physiological bone remodelling around the Bicontact® stem appeared to be achieved.

Bone remodeling after total hip arthroplasty with a short stemmed metaphyseal loading implant: finite element analysis validated by a prospective DEXA investigation.

In total hip arthroplasty (THA), short stemmed cementless implants are used because they are thought to stimulate physiological bone remodeling and reduce stress shielding. We performed a numerical investigation on bone remodeling after implantation of a specific short stemmed implant using finite element analysis (FEA). Overall bone mass loss was 2.8% in the entire femur. Bone mass decrease was mostly found in the proximal part of the calcar and in the greater trochanter due to the vast cross section of the implant, probably leading to stress shielding. In the diaphysis, no change in the apparent bone density was proven. The assumptions made agreed well with bone remodeling data from THA recipients who underwent dual-energy X-ray absorptiometry. However, the clinical investigation revealed a bone mass increase in the minor trochanter region that was less pronounced in the FEA. Further comparisons to other stem designs must be done to verify if the relative advantages of the investigated implant can be accepted.

Numerical simulation of strain-adaptive bone remodelling in the ankle joint.

BACKGROUND: The use of artificial endoprostheses has become a routine procedure for knee and hip joints while ankle arthritis has traditionally been treated by means of arthrodesis. Due to its advantages, the implantation of endoprostheses is constantly increasing. While finite element analyses (FEA) of strain-adaptive bone remodelling have been carried out for the hip joint in previous studies, to our knowledge there are no investigations that have considered remodelling processes of the ankle joint. In order to evaluate and optimise new generation implants of the ankle joint, as well as to gain additional knowledge regarding the biomechanics, strain-adaptive bone remodelling has been calculated separately for the tibia and the talus after providing them with an implant. METHODS: FE models of the bone-implant assembly for both the tibia and the talus have been developed. Bone characteristics such as the density distribution have been applied corresponding to CT scans. A force of 5,200 N, which corresponds to the compression force during normal walking of a person with a weight of 100 kg according to Stauffer et al., has been used in the simulation. The bone adaptation law, previously developed by our research team, has been used for the calculation of the remodelling processes. RESULTS: A total bone mass loss of 2% in the tibia and 13% in the talus was calculated. The greater decline of density in the talus is due to its smaller size compared to the relatively large implant dimensions causing remodelling processes in the whole bone tissue. In the tibia, bone remodelling processes are only calculated in areas adjacent to the implant. Thus, a smaller bone mass loss than in the talus can be expected. There is a high agreement between the simulation results in the distal tibia and the literature regarding. CONCLUSIONS: In this study, strain-adaptive bone remodelling processes are simulated using the FE method. The results contribute to a better understanding of the biomechanical behaviour of the ankle joint and hence are useful for the optimisation of the implant geometry in the future.

Finite element modelling of the canine and feline outer ear canal: benefits for local drug delivery?

Current therapeutic regimes of outer ear infections in dogs and cats aim at the application of efficient local therapeutics after cleaning of the acoustic meatus. One so far insufficiently answered question is if the local application of these substances results in an individually suitable drug concentration in the external ear canal. Thus, the purpose of the present study was to develop a finite element model to calculate the values of the different areas of the external acoustic meatus in dogs and cats in order to provide a tool for the benefit of an appropriate local drug dosage determination. A 3D finite element model (FEM), based on computer tomographic (CT) data sets of four dogs and two cats, was generated to determine areas and volumes of the outer ear canal. Furthermore, various ear therapeutics and cleansers were tested concerning their optimal distribution on 5 cm2 dog and cat skin. The data shows major variations of the area values of the external auditory canal in case of the different dogs but not in the examined cats. These results suggest that manufacturer's recommendations of the pharmaceuticals might be insufficient in terms of achieving an optimal drug concentration in the outer ear canal especially in larger dogs. In conclusion, the developed finite element model has shown to be suitable to calculate areas of the outer ear canal in cats and dogs and could be of help in context with the definition of optimal drug concentrations for a local drug delivery.

[Numerical investigations of the strain adaptive bone remodelling in the periprosthetic canine femur]. / Numerische Untersuchungen zum beanspruchungsadaptiven Knochenumbau im periprothetischen caninen Femur.

After surgical treatment of severe hip diseases with artificial joint prostheses aseptic loosening of the implants can occur. Unphysiologic load distribution in the periprosthetic femur and stress shielding by the prosthesis can result in bone remodelling processes. In particular a cutback of the bone mass is followed by an aseptic loosening of the prosthesis. In this context the understanding of bone remodelling processes in the prothetically treated femur is of outstanding interest for the optimisation of canine hip joint prostheses in the future. Therefore the main aim of this sudy was the numerical investigation on the change in the load distribution in the canine periprosthetic femur and the resulting bone remodelling after implantation of the cemented stem Bioméchanique. The investigations within this study were carried out using the Finite Element Analysis (FEA). The calculated bone density of the periprosthetic femur and the evolution of the mass loss show relevant stress shielding areas in different analysis regions. Therefore possible regions of aseptic loosening are indicated particularly in the proximo-medial femur. The here demonstrated numerical results are in agreement with clinical findings. For this reason the FEA-based method is a valuable tool for the prediction of bone remodelling processes.

Numerical investigations on the strain-adaptive bone remodelling in the periprosthetic femur: influence of the boundary conditions.

BACKGROUND: There are several numerical investigations on bone remodelling after total hip arthroplasty (THA) on the basis of the finite element analysis (FEA). For such computations certain boundary conditions have to be defined. The authors chose a maximum of three static load situations, usually taken from the gait cycle because this is the most frequent dynamic activity of a patient after THA. MATERIALS AND METHODS: The numerical study presented here investigates whether it is useful to consider only one static load situation of the gait cycle in the FE calculation of the bone remodelling. For this purpose, 5 different loading cases were examined in order to determine their influence on the change in the physiological load distribution within the femur and on the resulting strain-adaptive bone remodelling. First, four different static loading cases at 25%, 45%, 65% and 85% of the gait cycle, respectively, and then the whole gait cycle in a loading regime were examined in order to regard all the different loadings of the cycle in the simulation. RESULTS: The computed evolution of the apparent bone density (ABD) and the calculated mass losses in the periprosthetic femur show that the simulation results are highly dependent on the chosen boundary conditions. CONCLUSION: These numerical investigations prove that a static load situation is insufficient for representing the whole gait cycle. This causes severe deviations in the FE calculation of the bone remodelling. However, accompanying clinical examinations are necessary to calibrate the bone adaptation law and thus to validate the FE calculations.

[Measurement of the elastic properties of the cancellous bone in the femoral head of the dog]. / Messung der elastischen Eigenschaften der Spongiosa im Femurkopf des Hundes.

The degenerative wear and pathologic damage of the joints are reasons for total endoprotheses in man as well as in dogs. The main problem is the aseptic loosening of the protheses. By usig the finite-element-method, the total endoprothesis is designed with new features, with the purpose of preventing loosening and being better adapted to load transmission. In order to simulate the femur of the dog for the numerical analysis, a material law is developed. By taking into account the anisotropy and the local density of the cancellous bone in the femoral head, the young's modules are experimentally determined. The measurements are performed by ultrasonic methods on femoral heads of euthanised dogs. The results show planar isotropic cancellous bone.

Mechanical properties of femoral trabecular bone in dogs.

BACKGROUND: Studying mechanical properties of canine trabecular bone is important for a better understanding of fracture mechanics or bone disorders and is also needed for numerical simulation of canine femora. No detailed data about elastic moduli and degrees of anisotropy of canine femoral trabecular bone has been published so far, hence the purpose of this study was to measure the elastic modulus of trabecular bone in canine femoral heads by ultrasound testing and to assess whether assuming isotropy of the cancellous bone in femoral heads in dogs is a valid simplification. METHODS: From 8 euthanized dogs, both femora were obtained and cubic specimens were cut from the centre of the femoral head which were oriented along the main pressure and tension trajectories. The specimens were tested using a 100 MHz ultrasound transducer in all three orthogonal directions. The directional elastic moduli of trabecular bone tissue and degrees of anisotropy were calculated. RESULTS: The elastic modulus along principal bone trajectories was found to be 11.2 GPa +/- 0.4, 10.5 +/- 2.1 GPa and 10.5 +/- 1.8 GPa, respectively. The mean density of the specimens was 1.40 +/- 0.09 g/cm3. The degrees of anisotropy revealed a significant inverse relationship with specimen densities. No significant differences were found between the elastic moduli in x, y and z directions, suggesting an effective isotropy of trabecular bone tissue in canine femoral heads. DISCUSSION: This study presents detailed data about elastic moduli of trabecular bone tissue obtained from canine femoral heads. Limitations of the study are the relatively small number of animals investigated and the measurement of whole specimen densities instead of trabecular bone densities which might lead to an underestimation of Young's moduli. Publications on elastic moduli of trabecular bone tissue present results that are similar to our data. CONCLUSION: This study provides data about directional elastic moduli and degrees of anisotropy of canine femoral head trabecular bone and might be useful for biomechanical modeling of proximal canine femora.